Catalog Number 3095040 |
Device Problem
Difficult to Open or Remove Packaging Material (2922)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that the bag with the powder-component sticks together with the outer packaging and cannot be removed.No adverse patient consequences, no surgical delay reported.
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Manufacturer Narrative
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Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with this complaint was received for examination.Visual examination found the cement powder inner bag overlapping with the paper outer foil, confirming the reported allegation.It is only slightly harder to take the cement bag from the overlapping of the paper foil, but does not compromise the integrity and/or sterility of the final product.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Device history lot.1) (b)(4).2) date of manufacture: 09-dec-2021.3) any anomalies or deviations identified in dhr: none.No non-conformances were identified.4) expiry date: 30-nov-2023.5) ifu reference: (b)(4) rev 2 (alt rev b).A manufacturing record evaluation was performed for the finished device product code 3095040 and lot number 3660082.No non-conformances were identified.Please see details provide above.Device history review.A manufacturing record evaluation was performed for the finished device product code 3095040 and lot number 3660082.No non-conformances were identified.Corrected: d3, g1, h3.
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Search Alerts/Recalls
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